Cryocheck Hex LA

Activated Partial Thromboplastin

Precision BioLogic

The following data is part of a premarket notification filed by Precision Biologic with the FDA for Cryocheck Hex La.

Pre-market Notification Details

Device IDK193556
510k NumberK193556
Device Name:Cryocheck Hex LA
ClassificationActivated Partial Thromboplastin
Applicant Precision BioLogic 140 Eileen Stubbs Avenue Dartmouth,  CA B3b 0a9
ContactKaren Black
CorrespondentKaren Black
Precision BioLogic 140 Eileen Stubbs Avenue Dartmouth,  CA B3b 0a9
Product CodeGFO  
CFR Regulation Number864.7925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-10-23

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